(P173) Consensus for Integrating the Genital InFlammation Test (GIFT) device into Sexually Transmitted Infections management algorithms: Results from a two-round modified Delphi process

Background: Many women with common sexually transmitted infections (STIs) and bacterial vaginosis (BV) are asymptomatic. Asymptomatic STIs/BV are as inflammatory as symptomatic infections in women, and genital inflammation has been shown to increase HIV risk. A Genital InFlammation Test (GIFT) point-of-care device for detecting genital inflammation is being developed and evaluated through a multi-centre clinical study. We aimed to explore how GIFT could be further developed and used in current management algorithms, with a focus on low- and middle-income contexts.



Methods: We employed a modified Delphi approach in two rounds to gather input from expert participants in the field of STI management, including service providers, health programmers, researchers and policy makers. Both rounds’ questionnaires were designed with input from the study’s Scientific Advisory Board and administered as online surveys. Round one included open ended in-depth questions and generated qualitative data that were analysed thematically. Themes from round one were used to inform items presented in the round two survey in order to build consensus. In round two, responses were measured on a 5-point Likert scale from strongly agree to strongly disagree. Consensus was reached if more than 70% of participants selected strongly agree or agree.

Results: We had a total of 79 participants with 28 responses in round one and 70 in round two. Most participants were aged 25-54 years, and 58% of respondents were female. Consensus results showed that GIFT was more suitable for use as a screening tool rather than as a diagnostic tool. Attributes of GIFT prioritised for integration into STI management pathways include high sensitivity and specificity, affordability and ease of use. Potential barriers to its implementation and use include lack of provider awareness, high cost and stock-outs.

Conclusion: While GIFT promises to be a valuable point—of-care screening tool for detecting genital inflammation in asymptomatic women, strong evidence of high specificity and sensitivity is needed for it to be incorporated into STI management guidelines. Costs and affordability are key for its use and there is need to sensitize and train healthcare providers and patients on its use. Stakeholder consultations will facilitate its roll-out and sustained use within healthcare systems.